Tag: Switzerland

FDA starts iQOS review
Philip Morris said yesterday that the US Food and Drug Administration’s Center for Tobacco Products had initiated a substantive scientific review process in respect of its electronically heated tobacco product (EHTP), iQOS.
On May 24, the FDA had published the executive summary and research summaries supporting PMI’s Modified Risk Tobacco Product (MRTP) application for its EHTP, the company said in a note posted on its website.
‘In doing so, the agency announced that it will publish a notice in the Federal Register establishing a formal docket for public comments on PMI’s application at a later date,’ it said.
‘PMI submitted the application to the FDA on December 5, 2016.
‘Publication of PMI’s summaries initiates a substantive scientific review process by the FDA’s Center for Tobacco Products.’
PMI said the FDA had made the application summaries publicly available and that the agency would publish additional modules of PMI’s MRTP application on a rolling basis.
The FDA had established a one-year timetable for reviewing MRTP applications, though that timing was non-binding.
“We welcome FDA and public review of the comprehensive scientific evidence package that we submitted to the agency through its MRTP application process,” said Dr. Moira Gilchrist, PMI vice president corporate affairs of reduced-risk products.
“PMI’s application demonstrates our commitment to develop innovative, smoke-free technologies that can ultimately replace combustible cigarettes to the benefit of smokers, public health and society at large.”
Meanwhile, the Altria Group said that it was pleased that the FDA had filed PMI’s MRTP application.
It said that upon regulatory authorization by the FDA of PMI’s Premarket Tobacco Product application (PMTA), Philip Morris USA, an Altria company, would have an exclusive license to sell the electronically-heated tobacco product in the US.
PMI submitted the PMTA to the agency on March 31, 2017.
“PM USA is actively working on commercialization plans and we look forward to bringing this electronically-heated product to the US market,” said Sarah Knakmuhs, vice president heated tobacco products, PM USA.
“We are excited about the opportunity to add this product to our portfolio for adult tobacco consumers who are looking for an alternative to conventional cigarettes.”
May 26, 2017
IQOS safety questioned
A new study published in JAMA Internal Medicine reports that output from the Philip Morris International heat-not-burn product, iQOS, contains the same harmful components as are found in conventional tobacco cigarette smoke, according to a healio.com story relayed by the TMA.
Writing in the current publication, Dr. Reto Auer, of the Institute of Primary Health Care at the University of Bern in Switzerland, said PMI claimed that iQOS released no smoke because the tobacco did not combust and the tobacco leaves were only heated not burned. ‘However, there can be smoke without fire,’ he said.
‘The harmful components of tobacco cigarette smoke are products of incomplete combustion (pyrolysis) and the degradation of tobacco cigarettes through heat (thermogenic degradation).’
Auer and his colleagues analyzed and compared the contents and toxic compounds released in iQOS (iQOS Holder, iQOS Pocket Charger, Marlboro HeatSticks [regular], and Heets, Philip Morris SA) ‘smoke’ with that of conventional cigarettes (Lucky Strike Blue Lights).
Their study was said to have found that iQOS smoke contained similar levels of volatile organic compounds and nicotine as the smoke from conventional cigarettes, and that heat-not-burn products released higher levels of the polycyclic aromatic hydrocarbon acenaphthene than did conventional cigarettes.
The researchers called for further evaluation of the health effects of iQOS and recommended that heated tobacco products should be subjected to the same indoor-smoking bans as were conventional tobacco cigarettes.
May 25, 2017
New ways sought at WHO
Japan Tobacco International has urged the new leader of the World Health Organization, the former Ethiopian health minister Dr. Tedros Adhanom Ghebreyesus, to scrutinize carefully the organization’s current practices.
In a note posted on its website today, JTI said the World Health Assembly had just appointed the WHO’s new director general, amid controversy around the UN agency’s practices.
‘JTI has witnessed a number of abuses over the past years that are putting at risk three fundamental areas where businesses play a key role: transparency, sustainability and innovation,’ the note said. ‘We trust that current practices will be carefully scrutinized by the new WHO lead.’
On the question of transparency, JTI said that a culture of censorship and exclusion had developed, notably at the most recent Conference of the Parties to WHO’s Framework Convention on Tobacco Control (FCTC), where ostensibly open debates were held behind closed doors, from which journalists and the public were expelled, in direct contravention of the United Nation’s fundamental principles.
‘Any individual or organization who is seen to consult with anyone in the tobacco sector, including government representatives and experts with legitimate credentials, is in the WHO’s line of sight,’ the note said. ‘The WHO has so abused these practices that it is now putting pressure on other organizations, notably UN agencies, to follow the same dogmatic approach. It is therefore no surprise that the three WHO candidates have made transparency a key theme of their campaign. We expect the new director general to terminate this culture of secrecy.’
Turning to the question of sustainability, JTI said it was regrettable that the current WHO leadership had a narrow vision of the developing world’s realities. ‘Bullying tobacco farmers and governments to blindly follow its exclusion tactics, the WHO has been dangerously jeopardizing many programs which enhance tobacco communities’ livelihoods and meet the United Nation’s Sustainable Development Goals,’ the note said. ‘This includes Public Private Partnerships that have delivered concrete results which can only be achieved through sustained and collaborative efforts.
‘Conversely, if companies didn’t take their responsibility towards society seriously, the same organization would no doubt point fingers at them. It is crucial for the new WHO regime to acknowledge the invaluable expertise, resources and rigor that legitimate companies can and should continue to provide to communities where they are established.’
On the question of innovation, JTI said the WHO’s FCTC continued to recommend the prohibition or restriction of electronic cigarettes, even though these products did not contain tobacco and had the potential to reduce health risks. The company said it was looking forward to a new direction at the WHO that encouraged innovation and choice through research and development instead of ‘sliding into a contagious trend of product bans’.
“The WHO has become ideology-driven, engaging in a fight against businesses, tobacco growers, and vapers when it should open itself up to scrutiny and see the merit of initiatives that are actually delivering results, no matter what individual positions are,” JTI’s corporate communications vice president, Michelle McKeown, was quoted as saying.
“We trust the new WHO director general will take this opportunity to get back to basics by tackling the issue of transparency, keeping an objective view of sustainability in the developing world, and accepting that the innovation of next-generation products can help address some of the organization’s concerns.”
May 24, 2017
New product trialled
Philip Morris International said yesterday that it had released its second Scientific Update for Smoke-Free Products, a regular publication on its research efforts to develop and assess a range of potentially reduced-risk alternatives to cigarettes.
‘This issue of the Scientific Update focuses on novel approaches to e-vapor products,’ the company said in a note posted on its website. ‘Technology and innovation can improve user experience and continuously enhance a product’s potential to present less risk of harm than smoking. The focus of the issue details the product design and manufacturing behind MESH, the new generation of e-vapor technology PMI is currently test marketing in Birmingham (UK). MESH is one of the four smoke-free product types developed by PMI, along with IQOS.’
Professor Manuel Peitsch, PMI’s chief scientific officer, was quoted as saying that PMI was working to transition progressively its existing cigarette business to smoke-free products. “By offering a diverse portfolio of innovative and scientifically substantiated alternatives, we believe we can accelerate the switching of an even greater number of adult smokers who would otherwise continue to smoke and have a positive impact on public health.”
Meanwhile, Michele Cattoni, PMI’s vice president Technology and Operations, was quoted as saying that technological innovation was at the heart of PMI’s efforts to create a smoke-free future. “We have developed an e-vapor product which, like our other smoke-free technologies, incorporates the highest manufacturing and design standards to ensure the consistency and quality of the generated vapor.”
PMI says that beyond the development behind PMI’s MESH proprietary technology, the Update provides an overview of its assessment to date. ‘The issue also covers the latest studies, key peer-reviewed publications and presentations at scientific conferences,’ it said. ‘It is an important complement to PMI’s ongoing efforts to share its latest science, which include a dedicated website (www.pmiscience.com).
‘PMI’s extensive research and assessment program is inspired by the well-recognized practices of the pharmaceutical industry and in line with guidance of the US FDA for Modified-Risk Tobacco Products (MRTPs).
‘The company today employs over 400 world-class scientists, engineers and experts who conduct rigorous research, including laboratory and clinical studies, as well as ground-breaking systems toxicology. The assessment program also includes studies on actual product use and correct understanding of product communications, as well as post-market research.’
The Scientific Update is at: https://www.pmiscience.com/news/smoke-free-products-scientific-update.
May 23, 2017
Vapor pushing out smoke
Japan Tobacco Inc’s domestic cigarette volume sales during the three months to the end of March, at 23.0 billion, were 15.3 percent down on those of the three months to the end of March 2016, 27.2 billion.
JT reported today that the volume reduction was down mainly to the overall industry decline, which was partly caused by an increase in the vapor-product category.
‘Core revenue declined 10.4 percent [from ¥160.6 billion to ¥143.9 billion] due to the impact from the sales volume decline partially offset by the benefit from the retail price amendment of Mevius last year,’ the company reported.
‘Adjusted operating profit declined 13.0 percent [from ¥65.7 billion to ¥57.2 billion] due to lower core revenue and despite benefits from cost reduction initiatives.’
Meanwhile, Japan Tobacco International’s shipment volume during the three months to the end of March, at 91.7 billion, was down by 2.9 percent on that of the three months to the end of March 2016, 94.4 billion. At the same time GFB (global focus brands) volume fell by 0.5 percent from 66.4 billion to 66.0 billion.
JT said that JTI’s volume decline had been caused by industry-wide contractions in some markets, market share loss in the face of competitor-driven price discounting in the Commonwealth of Independent States, and unfavorable trade inventory adjustments when compared with the situation during the first quarter of last year.
‘GFB shipment volume was stable but grew excluding inventory adjustments, supported by strong performance in Iran and Taiwan,’ the company said. ‘Year-on-year total and GFB market shares increased in several key markets.
In US dollars, JTI’s core revenue at constant currency was said to have been stable at US$2,469 million [in Yen it was down 3.1 percent from ¥284.7 billion to ¥276.0 billion] as price/mix gains in several key markets offset the volume decline impact.
‘Adjusted operating profit at constant currency grew 1.5 percent [in Yen it was down 7.6 percent from ¥99.5 billion to ¥92.0 billion] driven by price/mix gains and cost reduction benefits including contribution from the manufacturing footprint optimization; while investments in emerging markets and emerging products continued.
‘On a reported basis, core revenue and adjusted operating profit declined 1.6 percent and 6.1 percent, respectively, due to unfavorable currency movements.’
“We are making good progress towards achieving our full year profit target,” said Mitsuomi Koizumi, JT’s president and CEO in presenting the company’s consolidated results.
“This quarter was impacted by unfavorable comparisons due to one-off specific factors in the previous year, but our underlying business performance and financial results were in line with our expectations.
“The international tobacco business delivered steady profit growth at constant currency, in a challenging operating environment.
“At the same time, we reaffirmed our robust operating base in the Japanese domestic tobacco business as assumed.
“It is encouraging that the pharmaceutical and the processed food businesses continued to contribute to the Group.
“I’m confident that we can achieve our full year target while continuing to invest for future sustainable growth amid a continuously challenging business environment.”
May 10, 2017
PMI to webcast meeting
Philip Morris International is due to host a live audio webcast of its 2017 annual meeting of shareholders at www.pmi.com/2017annualmeeting from 09.00 Eastern Time on May 3.
During the meeting, Louis C. Camilleri, chairman of the board, will address shareholders and answer questions.
André Calantzopoulos, CEO, will give the business presentation.
The audio webcast, which will be in listen-only mode, may be accessed also on iOS or Android devices by downloading PMI’s free Investor Relations Mobile Application at www.pmi.com/irapp.
An archived copy of the webcast will be available until 17.00 on June 1 at www.pmi.com/2017annualmeeting, where the presentation slides and script also will be available.
April 27, 2017
PMI’s cigarette volumes tumble
Philip Morris International’s cigarette shipment volume during the first quarter of 2017, at 173,552 million, was down by 11.5 percent on that of the first quarter of last year, 196,041 million.
Volume fell in each of the company’s regions: by 7.5 percent to 42,540 million in the EU; by 10.4 percent to 56,574 million in the EEMA (Eastern Europe, Middle East and Asia); by 15.5 percent to 55,142 million in Asia; and by 11.1 percent to 19,296 million in Latin America and Canada
But the company reported, too, a major increase in its shipments of heated tobacco products, which in the first quarter of 2016 amounted to 453 million but which by the first quarter of this year had risen to 4,435 million.
Shipments of heated tobacco products were up from 16 million to 184 million in the EU; from two million to 105 million in the EEMA; and from 435 million to 4,145 million in Asia. In Latin America and Canada, where there had been no shipments of heated tobacco products in the first quarter of 2016, PMI recorded one million in the first quarter of this year.
Shipments of cigarettes and heated tobacco products during the first quarter of 2017, at 177,987 million, were down by 9.4 percent on those of the first quarter of 2016, 196,494 million, with shipments down by 7.1 percent in the EU, by 10.2 percent in the EEMA, by 9.7 percent in Asia, and by 11.1 percent in Latin America and Canada.
‘PMI’s total shipment volume of cigarettes and heated tobacco units decreased by 9.4 percent, or by 7.8 percent excluding net estimated inventory movements, reflecting a challenging comparison with the first quarter of 2016, which declined by a more modest 1.1 percent, as well as ongoing declines of primarily low-price volumes in specific markets, such as
Pakistan and the Philippines,’ the company said in reporting its results. ‘The first quarter of 2016 also benefited from the favorable estimated impact of the leap year.
‘PMI’s cigarette volume decreased by 11.5 percent due to: the EU, principally Italy and Spain, partly offset by Poland; EEMA, mainly North Africa, primarily Egypt and Tunisia, as well as Russia and Ukraine; Asia, principally Indonesia, Japan, Korea, Pakistan and the Philippines; and Latin America & Canada, principally Argentina, Canada and Mexico. ‘The decline in PMI’s cigarette shipment volume was partly offset by higher heated tobacco unit shipment volume of 4.4 billion units, up from 453 million units in the first quarter of 2016, driven by Japan.
Taking cigarette shipments alone, Marlboro shipments of 62,399 million were down by 8.2 percent; L&M shipments of 21,913 million were down by 7.5 percent; Parliament shipments of 9,199 million were down by 9.3 percent; Bond Street shipments of 8,485 million were down by 12.7 percent; Chesterfield shipments of 11,544 million were up by 13.4 percent; Philip Morris shipments of 10,608 million were up by 15.2 percent; and Lark shipments of 6,526 million were up by 0.4 percent. Shipments of other brands, taken together, were down by 26.9 percent to 42,878 million.
PMI said that its reported diluted earnings per share, at $1.02, were up by $0.04 or 4.1 percent on those of the first quarter of 2016.
Adjusted diluted earnings per share, at $0.98, were flat.
Reported net revenues of $16.6 billion were down by 1.4 percent, while net revenues, excluding excise taxes, at $6.1 billion, were down by 0.3 percent.
Reported operating income of $2.4 billion was down by 3.1 percent, while operating companies’ income of $2.5 billion was down by 2.2 percent, and adjusted operating companies’ income of $2.5 billion was down by 2.2 percent.
“Our results were in line with our previously communicated expectation of a relatively weak first quarter, due to lower cigarette volume – primarily related to low-price brands in specific markets where the impact on our profitability was limited – and certain timing factors,” said CEO André Calantzopoulos.
“We are fully on track to deliver our full-year EPS guidance, driven by robust pricing and accelerating IQOS volume growth. We anticipate a combined cigarette and heated tobacco unit volume decline of 3 percent to 4 percent for the full year.
“It is extremely encouraging that already today, despite persistent capacity constraints, 1.8 million consumers have effectively stopped smoking and have switched to our heat-not-burn alternative, IQOS.”
April 21, 2017